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Radiation-Free breast cancer treatment? new trial tests skipping it after chemo success

NCT ID NCT05866458

Disease control Sponsor: Ontario Clinical Oncology Group (OCOG) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study is testing whether women with early-stage breast cancer that has not spread to lymph nodes can safely skip radiation therapy after a lumpectomy, if their tumor completely disappeared with chemotherapy. The trial will enroll 352 women and follow them for cancer recurrence in the same breast. The goal is to reduce unnecessary treatment side effects without increasing the risk of cancer coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy omission
What this could lead to
If successful, this could allow many women with early breast cancer to avoid radiation and its side effects after a good response to chemotherapy.
What could go wrong
This is a phase 3 trial, but it only includes a specific group (node-negative, complete response). The risk of cancer returning in the breast without radiation is unknown and may be higher than expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 352 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Written informed consent will be obtained from all eligible patients who agree to participate. Until the patient has been completely informed of the study, has freely consented to take part in the study and has signed and dated an informed consent form that has received documented approval by an authorized Research Ethics Board (REB), no study related assessments, including those required for screening can be performed.

Ages

50 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type). 2. Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy. 3. Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy. 4. Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified. 5. Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection). 6. Final pathology demonstrating a pCR \[defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)\]. Exclusion Criteria: 1. Age less than 50 years. 2. Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease). 3. Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast). 4. Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible. 5. Synchronous contralateral in-situ or invasive breast cancer. 6. BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer. 7. Other previous non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers or other cancers curatively treated with no evidence of disease for ≥ 5 years. 8. Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of treatment). 9. Patients with HR+ (hormone receptor) disease who are not planned to have endocrine therapy initiated. 10. Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy. 11. ECOG (Eastern Cooperative Oncology Group) performance status \> 3. 12. Inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BC Cancer - Centre for the North

    RECRUITING

    Prince George, British Columbia, V2M 7E9, Canada

  • CHU de Quebec - Universite Laval

    RECRUITING

    Québec, Quebec, G1R 2J6, Canada

  • CHUM - Centre Hospitalier de L'Université de Montréal

    RECRUITING

    Montreal, Quebec, H2L 4M1, Canada

  • Cancer Centre of Southeastern Ontario at Kingston

    RECRUITING

    Kingston, Ontario, K7L 5P9, Canada

  • Centre Hospitalier Trois Rivieres Ste-Marie

    RECRUITING

    Trois-Rivières, Quebec, G8Z 3R9, Canada

  • Centre hospitalier de Lanaudière

    RECRUITING

    Saint-Charles-Borromée, Quebec, J6E 6J2, Canada

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Juravinski Cancer Centre

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Latrobe Regional Health

    RECRUITING

    Traralgon, 3844, Australia

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, 1871, Australia

  • Maroondah Hospital

    RECRUITING

    Box Hill, 3128, Australia

  • Mater Hospital Sydney

    RECRUITING

    North Sydney, New South Wales, 2060, Australia

  • McGill University Health Centre (MUHC)

    RECRUITING

    Montreal, Q, H4A 3J1, Canada

  • Monash Medical Centre -Moorabbin

    RECRUITING

    Bentleigh East, Victoria, 3165, Australia

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Prince of Wales Hospital

    RECRUITING

    Randwick, 2031, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Royal Brisbane and Women's Hospital

    RECRUITING

    Herston, Queensland, 4029, Australia

  • Royal Perth Hospital

    RECRUITING

    Perth, 6000, Australia

  • Royal Victoria Regional Health Centre

    RECRUITING

    Barrie, Ontario, L4M 6M2, Canada

  • Sir Charles Gairdner Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • St. Vincent's Hospital Melbourne

    RECRUITING

    Melbourne, Victoria, 3065, Australia

  • Sunnybrook Health Sciences -Odette Cancer Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Thunder Bay Regional Health Sciences Centre

    RECRUITING

    Thunder Bay, Ontario, P7B 6V4, Canada

  • Tweed Valley Hospital

    RECRUITING

    Cudgen, Cudgen, 2487, Australia

  • Victorian Breast & Oncology Care (VBOC)

    RECRUITING

    East Melbourne, Victoria, 3002, Australia

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

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